NCT07531693

Brief Summary

The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Mar 2027

Study Start

First participant enrolled

February 19, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

HR+/HER2- Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Abemaciclib persistence rate

    Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

    6 months after therapy start

Study Arms (1)

High-risk HR+/HER2- early breast cancer patients

High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected from up to 30 study sites across Germay. Sites will be selected from certified breast cancer centers that have experience providing adjuvant treatment to breast cancer patients.

You may qualify if:

  • Femal patients age 18 or older at time of informed consent
  • Confirmed diagnosis of HR+/HER2- early breast cancer (no distant metastasis)
  • Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC)
  • Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025

You may not qualify if:

  • Locally advanced or metastatic breast cancer
  • Male patients
  • Patients with contraindication(s) for abemaciclib therapy according to SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Study Officials

  • Peter A. Fasching, Prof. Dr. med.

    Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

    STUDY CHAIR

Central Study Contacts

Sponsor's study office

CONTACT

+49 15739466438studien@ifg-erlangen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start

February 19, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

DE(1)